The GOC's consultation on standards for optical business

Our response to the GOC's consultation on Business Standards, August 2018

The consultation

In June 2018 the GOC consulted on new draft standards for registered optical businesses, to replace the current Code of Conduct for business registrants.

The AOP’s response

Part 1 – Overview

We welcome the GOC’s consultation on draft standards for optical businesses. Many of our members work in optical businesses as employees or locums. New standards have the potential to guide businesses in helping these members to meet their own obligations under the GOC’s standards for individual registrants. However, to achieve this the standards will need to be clear about the responsibilities of businesses and individuals, and effectively enforced.

We also represent members who are owners or directors of optical practices. For these members it is vital that the new standards are clear and proportionate, and do not impose unnecessary new costs or administrative burdens.

This consultation response is informed by our members’ views, including discussion at a meeting of the AOP Council. We have discussed the draft standards with GOC staff during the consultation period, and their explanation of their policy intentions has informed this response. We are grateful to them for their help.

In part 2 of this response we make some important general points:

The draft standards need to be revised so that optical businesses, their staff (including individual registrants) and the public can understand clearly what the GOC expects of registered businesses

In revising the standards, the GOC should only impose new burdens on optical businesses where this is justified, risk-based and proportionate

The GOC should give businesses and individual registrants more information about how it will use and enforce the standards

While we support the GOC’s long term policy aim that all optical businesses performing restricted functions should have to register and comply with the standards, this should not become mandatory until the law enables all businesses to register – at present some cannot do so without changing their legal structure or governance arrangements.

In part 3 of this response we provide detailed comments on many of the draft standards, including examples of where the general points listed above apply to particular standards.

The GOC’s consultation process includes an online survey. Some of the survey questions, about personal experience of using optical practices, are not directly relevant to the AOP. The remaining questions are relevant, but are largely high-level (for instance, will the draft standards have a positive or negative impact on different groups?). We have not completed the survey, because until the issues discussed in this consultation response have been resolved, it is difficult for us to give meaningful answers on behalf of our members to many of these questions. Overall, we think the proposed standards do have potential to be helpful to businesses, their staff and the public, but that this potential will only be realised if the standards are revised and clarified.

We therefore urge the GOC to consult further on the business standards, if only informally, once they have been revised in the light of this consultation. This will allow us and other stakeholders to give informed answers to these crucial questions before the new standards are implemented.

Part 2 - General points on the draft business standards

The draft standards need to be revised so that optical businesses, their staff and the public can understand clearly what the GOC expects of registered businesses

We think many of the draft standards need to be revised so that the responsibilities of all parties are clear, and businesses can readily understand what the GOC expects of them. We understand from our discussions with GOC staff during the consultation period that they do intend to revisit the drafting of the standards following this consultation.

Part 3 of this response highlights particular areas where we think change is needed. Once these changes have been made, we think the standards as a whole will need a further ‘big picture’ review to check that the different standards are consistent with each other, and that there is no overlap or conflict between the various requirements set out in the standards – and further consultation with stakeholders, as we have suggested above.

In revising the standards, the GOC should only impose new burdens on businesses where this is justified, risk-based and proportionate

In our detailed comments in Part 3 of this response, we have noted several requirements that exceed (or could exceed) what is currently required by the GOC or by NHS contracts. These include:

Standard 1.1.1 requires all registrants to have public liability insurance, which is currently only a requirement for practices performing GOS

Standard 1.2.4 could lead to more staff being required to have a DBS check than at present

Standard 2.3.3 requires businesses to audit patient records regularly, which is not currently a requirement in ‘Quality in Optometry’ and may not be realistic for small practices.

Where the standards impose new requirements that carry costs or administrative burdens, the GOC should assess the costs and benefits of these changes and invite stakeholders’ views on its analysis, so that businesses and others can understand what is changing, and challenge the proposals where necessary. In particular, where the standards introduce new minimum requirements (as opposed to recommending good practice) the GOC should make the case for this.

The papers for the February 2018 GOC Council said an impact assessment would be published alongside the draft standards, but this has not been done. We understand the GOC intends to use responses to this consultation to inform its view of the impact of the new standards. The GOC should publish and invite views on its assessment before any draft standards imposing new regulatory burdens or costs are finalised and implemented.

More generally, several of the draft standards have been framed more widely than necessary, in a way that could unnecessarily impose significant new burdens or costs on businesses. These standards should be reframed so as to meet the GOC’s policy objectives while imposing no more burdens than necessary. We discuss these in part 3 of this response – examples include:

Standard 1.2.6, on restricting trading in areas of concern, is drafted broadly and could be interpreted in ways that cause business unnecessary disruption

Standards 2.2.1, 2.2.3 and 2.2.5 expose registrants to the possibility of facing different hearings in different forums on the same facts, which is onerous and unnecessary. We understand the GOC’s policy aim is to be able to act where a breach of (non-optical) law by a business registrant may damage public confidence or pose a risk to public protection. We think this can be achieved while framing the requirement more proportionately

Standard 2.2.4 requires registrants to ensure that other parties have appropriate qualifications and registered status, which is unrealistic in practice for reasons we explain in part 3 of this response.

The GOC should give businesses and individual registrants more information about how it will use and enforce the standards

Individual optical professionals can face unreasonable pressures as a result of some business practices, such as insufficient time for tests, or pressure to make sales when not clinically necessary. These stresses and pressures were confirmed by our health and wellbeing member survey research carried out in 2017.

We have argued in the past that some of the GOC’s current standards for individual registrants are more appropriately responsibilities for the business employing the individual. The introduction to the draft business standards helpfully reflects this by saying that mandatory regulation for businesses would create a consistent approach to “…activities that tend to be in the control of businesses as opposed to individual registrants”.

The new business standards could help to reduce the pressures on employed members. For instance:

Standard 1.3.3 which requires the business to prevent commercial pressures inhibiting staff communicating with patients

Standard 1.4.4 which states “do not impose sales targets that have an adverse effect on patient care”

Standard 3.4 which expects businesses to support staff to understand local systems of referral – we think this could be especially helpful for locum (non-employed) staff, and we have suggested in part 3 of this response that locums should be specifically mentioned in this standard.

However, our members have asked how this would work in practice, and how businesses will be held accountable for compliance with the standards. While the new business standards are much more detailed than the current Code of Conduct for businesses, they are still less detailed than the individual standards.

From the perspective of the individual employee or locum it would be helpful if the GOC could provide more information about how businesses can support staff to meet individual standards, and how the GOC will hold businesses to account for their performance against the business standards. We have suggested to GOC staff that this could be done via a new section in the preliminary wording of the standards, titled something like “How does the GOC use and apply the standards?”.

Business registration should not become mandatory until the law enables all businesses to register

We support the GOC’s policy aim that all optical businesses performing restricted functions should ultimately have to register and comply with the standards. However, the Opticians Act currently prevents some businesses from registering unless they change their own legal structure or their governance arrangements. For instance, one of our members has a business which is a limited liability partnership (LLP) with two directors, who are partners with equal voting rights. Only one of them is an individual registrant. The business cannot therefore meet the Opticians Act requirement to have “a majority of its directors” as individual registrants.

This business could only register with the GOC by changing its corporate structure or introducing another partner. These are significant steps, which can also have implications for a business’s NHS contracts. We do not think businesses should have to take those steps simply as a consequence of compulsory registration being introduced for businesses carrying on restricted functions.

We think the rules should allow any business to register as long as it is capable of meeting the standards. As we have discussed with GOC staff, the requirement for a majority of directors to be individual registrants will be less relevant if business registrants are required to comply with the new business standards, and changes to the registration rules should not have unintended consequences for businesses that cannot currently register.

Until the law or NHS contracts are changed to require all relevant optical businesses to register with the GOC, it is also important that the new business standards do not actively discourage new or continued registrations by imposing unreasonable regulatory burdens on registrants. This underlines the importance of ensuring there is a good case for any new burdens imposed by the standards.

Part 3 - Detailed comments on the draft standards

Introductory text

‘Who do these standards apply to?’ The list of roles covered by the word ‘staff’ on page 3 of the standards includes “any other staff in public-facing roles”. We do not think the scope of the standards should be limited to staff in public-facing roles, given that the final paragraph of the introductory text says,“even if some members of staff do not have direct contact with patients, their decisions, behaviour and/or working environment can still affect patient care and safety”. It would be better to focus on staff whose decisions may affect patient care, as discussed in our comments on standard 3.1.1 below.
‘When there are concerns’ As noted in part 2 of this response, we suggest that the introductory text should include a section along the lines of “How does the GOC use and apply the standards?” which would explain the GOC’s expectations of businesses and the circumstances in which it would expect to hold businesses to account against the standards, particularly through formal action such as fitness to carry on business proceedings. This could expand on the current material about what will happen where there are concerns.

Standard 1

1.1.1 Public liability insurance is not currently a requirement for all optical practices, although it is for those performing GOS work. The GOC should set out the rationale for making it a requirement for non-GOS practices, including the anticipated costs and benefits of this change.

1.1.2 The drafting in this standard is inconsistent (“ensure” vs “take reasonable steps”). It would be clearer to frame this as: “Take reasonable steps to ensure that your staff have appropriate professional indemnity insurance to cover their activities where necessary”.

1.1.4 The standard should expand on the meaning of “reputable source” in this context. We suggest the focus here should be on taking reasonable steps to ensure that equipment and medication is of suitable quality. The use of a reputable supplier would then be something that an optical business could point to if asked to demonstrate how it met this standard.

1.1.11 This standard is unrealistic as drafted – it would be better framed as “take reasonable steps to prevent unauthorised access to equipment and restricted areas”.

1.2.1 The standard requires businesses to ensure that “all relevant staff” have undertaken “appropriate” safeguarding training. The Optical Confederation’s safeguarding guidance recommends that all optometrists, contact lens and dispensing opticians should complete safeguarding training in line with Level 2 in the intercollegiate Safeguarding Guidance, and refresher training, and that all other, non-registered practice staff should complete training in line with Level 1. Given that, we are not sure the qualifier “relevant” is necessary or helpful here.

1.2.4 The drafting does not make it clear which practice staff would be considered “relevant” for the purpose of the DBS requirement. Until now, registered practitioners have not required a DBS check for GOS work except at application, so many older GOS-only practitioners may never have had a DBS check. We understand the GOC’s view is that the meaning of “relevant” here will depend on the risk associated with the context in which a practice is working. For instance, it may be more appropriate for practitioners to have a DBS check if they are doing domiciliary work than if they are working on a practice’s premises. It would be helpful if the wording of this standard made that clear.

1.2.5 We think this standard logically fits straight after 1.2.1 which also relates to safeguarding.

1.2.6 This requirement is very broad as drafted, and could be interpreted in ways that cause businesses unnecessary disruption, so we think GOC should produce guidance on it for business registrants. For instance, what evidence/criteria should businesses refer to when deciding if continuing to carry on business in a given area “may damage the reputation of the profession”? Would this be in response to a GOC request?

1.3.1 What sort of action would be expected here, and why does the GOC think businesses should specifically promote awareness of the GOC standards, which are not framed as patient-facing documents? We are not sure that a standard on this issue is needed at all. If the GOC consider that it is, we suggest it should be framed more generically, e.g. “Promote awareness and understanding of the role of the GOC in patient and public protection”. It would also be helpful if the GOC could explain what sort of concrete steps it would expect a business to take to comply with this standard.

1.3.2 We think this standard should only require businesses to take reasonable steps – it is too broad as drafted.

1.3.3 Members working in optical practices have broadly welcomed the provision on commercial pressures, but are unsure how it would be enforced. This could usefully be explained in the new introductory material we have suggested, about how the GOC will use and apply the standards.

(ii) Practice owners have raised concerns that if interpreted broadly, this requirement could be unrealistic for many business models. We think the requirement should be framed in a way that makes clear it is to be interpreted proportionately, bearing in mind the context and the risk of a patient suffering detriment in each case. We understand that the GOC intends to refer to peer group norms when applying this standard, bearing in mind that optical practices provide healthcare in a business context.

(iii) We assume the standard is intended to cover all activities within an optical practice, but the wording “before care is provided” could be read as only applying to initial interaction with a patient (e.g. before a sight test is provided or appliances are dispensed). The drafting should be clarified.

1.3.4 We asked GOC staff what sort of actions by a business might fall foul of this requirement. We understand the GOC does not want to cut across the commercial judgement of optical businesses, and that the standard is intended to focus on the impact that a change of product or appliance could have on the individual patient. As drafted the standard applies to “any” change to a product or appliance, including things that could have no impact on the care of patients. We suggest the GOC considers reframing it more narrowly.
1.3.5 What sort of action does the GOC expect businesses to take to comply with this standard? Is there an implied training requirement, and (if so) how would that link to CET requirements for individual registrants?

1.3.6 The use of “all” and “any” makes this requirement potentially very wide and unrealistic – it should be framed more precisely.

1.3.7 We do not think it would be realistic to expect a business to “require” this. We suggest this should be framed as “support” rather than “require”, as in standards 1.3.5 and 1.3.6.

1.4.4 (i) This requirement might fit better in section 2.1 of the standards, or in standard 3.1.2.

(ii) We asked GOC staff to clarify what is meant by “an adverse effect on patient care”. For instance, pressuring a patient to buy eye drops that they don’t need is not ethical, but would be unlikely to cause adverse clinical effects. We understand that the GOC intends this standard to cover ethical as well as clinical issues, and we suggest that the drafting should be clarified accordingly.

Standard 2

2.1 The title of this standard and the statement in the preamble that “you need to ensure that the way your business is run is transparent” are wider than the specific requirements set out in 2.1.1 – 2.1.10, which all concern candour and/or complaint handling. The text in the preamble could be read as referring to wider issues such as the finances of a business, which are not relevant to these standards. We think the title of the standard and the preamble should be narrower in scope.

We appreciate that the business standards need to deal with the risk that a breach of non-optical regulatory requirements by an optical business may damage public confidence, or even (in extreme cases) pose a risk to patient safety. However, the standard as drafted means that any alleged breach of the relevant legal requirements could leave a business registrant facing different hearings in different forums on the same facts.

This is onerous and unnecessary, particularly if the matter has been managed in another forum, or could be better managed in another forum (for instance because the issue relates to a point of law in a field outside the GOC’s expertise). We raised this with GOC staff, and we understand that the GOC does not wish to start making findings in areas of the law that lie outside its expertise.

To avoid that problem, while ensuring that the GOC can take regulatory action where necessary to protect the public, we suggest that this standard (and/or the GOC’s public guidance on its approach to enforcing the standard) should be framed so that GOC action can usually only be triggered where:

a breach of the law has been established by the relevant regulator (e.g. the Information Commissioner’s Office for data protection law) or a court, and

the breach could affect public confidence in the registered business’s fitness to carry on business, or could pose a risk to patient safety.

This could be widened to cover any breach of the law that could have these effects – not just breaches of the law on advertising, data protection and equality.

It could then be supplemented by a provision enabling the GOC to take appropriate interim action in urgent cases where a breach of the law has been alleged but not yet established, and where the nature of the allegation demonstrates a need for the GOC to act in order to protect the public.

2.2.4 This requirement is not realistic. In many cases registrants do not have control over the identity of the individual or organisation who will be responsible for treating the patient after referral (e.g. where a referral is directed by a referral management centre). Even where they do, it is not clear how registrants could “ensure” that individuals actually have the relevant qualifications. And it should normally be reasonable for registrants to assume that NHS hospital trusts and the people who work in them have the necessary qualifications and registration.

We raised this with GOC staff, and understand that the standard is not intended to require practices to validate their routine referral protocols. Rather, it is aimed at ensuring that all referrals are made with appropriate care, particularly when referring a patient to a care provider that is not previously known to the practice (for instance at the request of the patient). Given that, the standard should be reframed as a requirement to “take reasonable steps where appropriate”.

2.3 The nature of the formal clinical governance processes that an optical practice has in place may reasonably vary depending on the size of the practice. For instance, a sole trader or a very small practice with only one or two clinical employees is unlikely to have formal mechanisms for raising concerns about risks. It would be helpful if the preamble to standard 2.3 could reflect this, to reassure businesses that the requirements on them will be interpreted proportionately.

2.3.3 Auditing records is not currently a Quality in Optometry requirement, so this is another new requirement (with associated costs) and may not be realistic for very small practices e.g. sole traders. We are unsure how good the evidence is for the clinical benefit of record audits, and our members have differing views on the clinical value of a very small practice auditing its own records.

The standard requires “regular” audits but does not suggest how frequent these should be. We suggest framing this requirement in a risk-based way, enabling businesses to decide when it is appropriate to carry out audits in order to maintain good standards of care.

Standard 3

3.3 We think the title of this standard should be something like “Staff are adequately supervised and supported” since the concept of supervision is usually associated with pre-registration staff.

3.1.1 We asked GOC staff why this standard only applies to staff in public-facing roles, given that It is also relevant to e.g. staff in clinical advisory roles. We understand the GOC is trying to avoid imposing unnecessary requirements on ancillary staff, such as cleaners. We suggest the standard is therefore reframed so that it applies to any staff in a practice whose decisions or actions may affect the care of patients, whether or not they are in a public-facing role.

3.1.3 As with standard 1.3.3, practice owners have raised concerns that if interpreted broadly, this requirement could be unrealistic for many business models.

3.1.4 The drafting here does not really seem appropriate to small practices, which are likely to have relatively informal internal communication methods. It could be redrafted to cover all sizes of business, e.g. “Enable your staff to discuss making difficult decisions internally, if they need to”.

3.1.5 We asked GOC staff how this standard would apply to optical practices that are part of a larger structure in which product decisions are taken at ‘head office’, rather than by the registrant business itself. We understand the GOC’s aim is to ensure that the business environment as a whole enables appropriate treatment for each individual patient, and that in enforcing the standard the GOC will consider the chain of causation. It would be helpful to make this clear in the standard.

3.1.6 We asked GOC staff whether the “learning and development in professional decision-making” referred to in this standard is covered by the GOC’s CET (or future CPD) requirements for optical registrants, or is wider in scope. We understand it is intended to be wider than the CET requirements, and support a “culture of candour”. It would be helpful to make this clear.

3.2 This standard refers throughout to “staff”, and in standard 3.2.1 to “those employed” in registered roles. Many optical businesses use locum staff, who are not employees, and some of the requirements in this standard seem as relevant to locum staff as to employed staff.

This standard should therefore be revised to make clear which of the requirements in 3.2.1 – 3.2.6 do and do not apply to locum staff. Our view is that:

Standards 3.2.1 (GOC registration), 3.2.3 (induction of new staff) and 3.2.4 (working within competence) should apply to locums, but the induction standard should not enable businesses to require locums to undertake additional unpaid work

The requirement in standard 3.2.6 to support registrants to meet the individual standards of practice should apply to locums, but the requirement to support locums to meet their CET requirements should not (although contractors should still be encouraged to process CET claims on behalf of locums where relevant)

3.2.5 We asked GOC staff whether the word “appropriate” in this standard is intended to reflect the fact that small practices may not need a highly formalised system. We understand the GOC expects that where a member of staff has “important” training needs, these should be formally recorded. It would be helpful to make this clear in the wording of the standard.

3.4 We think this standard (or standard 3.2.3) should refer specifically to the need to ensure that locums have access to information about local referral protocols.

3.4.1 When managing the quality of patient referrals, it is important to guard against under-referral (which can lead to a potentially serious clinical problem not being treated) as well as over-referral (which is wasteful of NHS resources). The use of “only” in this standard could tilt optical practices towards minimising referrals, with potential risks to patient safety. To manage this risk, we suggest that this standard should be reworded along the lines of “support staff to make referrals whenever (but only when) appropriate and clinically justified”.

3.4.3 The drafting (“make sure that further information can be requested”) looks odd – we suggest this should be redrafted along the lines of “support staff in requesting further information…”.

3.4.5 Some practices do not allow staff sufficient time to keep proper records, and/or provide inadequate recording systems for this purpose (e.g. using very small record cards). We therefore suggest this is redrafted along the lines of:

“Require and enable staff to keep patient records that are clear, legible, contemporaneous and sufficiently detailed to be accessible to another healthcare professional, and allow sufficient time for them to do so”.

If you would like any more information, please contact a member of the policy team on policy@aop.org.uk.